Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

NCT02613676 | Completed DMC

• 1 other identifier: TcBScreening
• Study Type: interventional
• Target: 1,858
• Locations: 1 country
• Sites: 1

Brief Summary

In South Africa, healthy term newborns are usually discharged early (\<72 hours after delivery). Many studies have shown that hospital readmission rates have increased with this practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have already been discharged putting the infant at increased risk of severe hyperbilirubinemia. Severe neonatal jaundice still constitutes an important cause of neonatal mortality and morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before hospital could help in early identification of hyperbilirubinemia and early intervention and potentially prevent unwanted consequences like bilirubin induced neurological dysfunction. However, there are conflicting recommendations on the use of universal transcutaneous bilirubin screening for jaundice in all newborns before hospital discharge.

Conditions

Neonatal Jaundice; Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Readmission for hyperbilirubinemia

  The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion

  Up to two weeks

Secondary Outcomes (4)

• Phototherapy before discharge

  Up to two weeks

• TsB > 427 umol/l or TsB > threshold for exchange transfusion

  Up to two weeks

• Length of hospital stay (days)

  Up to two weeks

• Blood draw for total serum bilirubin

  Up to two week

Study Arms (2)

TcB screening before discharge

EXPERIMENTAL

Participants in this group will be screened for jaundice using the JM 105 transcutaneous device. The TcB value will be plotted on the Bhutani nomogram to assess the risk category. Infants who are categorised as high risk according to the nomogram will require blood sampling for TsB and assessment for need for phototherapy.

Device: Transcutaneous bilirubin screening

Standard care (visual inspection)

OTHER

Participants in this group will be managed routinely according to the current standard of care where babies are assessed for jaundice by visual inspection. Babies in this group will require blood draw for TsB if there are visibly jaundiced

Other: Standard care (Visual inspection)

Interventions

Transcutaneous bilirubin screening DEVICE

Transcutaneous bilirubin screening before hospital discharge and assessment of risk category according to the Bhutani nomogram

TcB screening before discharge

Standard care (Visual inspection) OTHER

Participants in this group will be assessed for jaundice by visual inspection. Blood draw for TsB will be drawn only if the participant is visibly jaundiced.

Standard care (visual inspection)

Eligibility Criteria

• Age: 6 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All newborns ≥ 35 wks gestational age and ≥ 1800g
• Babies who who are \< 72 hours of life

You may not qualify if:

• Prior use of phototherapy
• Major congenital anomaly
• Babies born \< 35 wks gestational age or \< 1800g

Sponsors & Collaborators

• University of Stellenbosch: lead
• Stanford University: collaborator

Study Sites (1)

Tygerberg Hospital

Cape Town, Western Cape, 7560, South Africa

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Interventions

Standard of Care; Watchful Waiting

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care

Study Officials

• Charles I Okwundu, MBBS, MPH

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

• Vinod K Bhutani, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 24, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

ZA (1)